FDA.reportPublic FDA data

McKie Thumb Splint Neonatal

Primary DI
00810026960086
Brand
McKie Thumb Splint Neonatal
Company
McKie Splints, LLC
Model
N1-R Pink
Catalog number
N1-R Pink
Device description
McKie Thumb Splint - Neonatal Size 1 - Right Hand - Pink Color
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810026960086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810026960086008100269600868100269600860810026960086

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2187202844info@mckiesplints.com

Regulatory Flags#

DUNS number
028744055
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810026962165McKie Thumb Splint AdultA1-L Black2023-06-29
00810026962189McKie Thumb Splint AdultA1-L Pink2023-06-29
00810026962196McKie Thumb Splint AdultA1-L Red2023-06-29
00810026962202McKie Thumb Splint AdultA1-L Royal2023-06-29
00810026962219McKie Thumb Splint AdultA1-L Tan2023-06-29
00810026962226McKie Thumb Splint AdultA1-R Black2023-06-29
00810026962240McKie Thumb Splint AdultA1-R Pink2023-06-29
00810026962257McKie Thumb Splint AdultA1-R Red2023-06-29
00810026962264McKie Thumb Splint AdultA1-R Royal2023-06-29
00810026962271McKie Thumb Splint AdultA1-R Tan2023-06-29
00810026962288McKie Thumb Splint AdultA2-L Black2023-06-29
00810026962301McKie Thumb Splint AdultA2-L Pink2023-06-29
00810026962318McKie Thumb Splint AdultA2-L Red2023-06-29
00810026962325McKie Thumb Splint AdultA2-L Royal2023-06-29
00810026962332McKie Thumb Splint AdultA2-L Tan2023-06-29
00810026962349McKie Thumb Splint AdultA2-R Black2023-06-29
00810026962363McKie Thumb Splint AdultA2-R Pink2023-06-29
00810026962370McKie Thumb Splint AdultA2-R Red2023-06-29
00810026962387McKie Thumb Splint AdultA2-R Royal2023-06-29
00810026962394McKie Thumb Splint AdultA2-R Tan2023-06-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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